Table 2.
Recommendations for treatment of patients with active psoriatic arthritis despite treatment with an OSM (PICOs 16–25; 67–69; 76–78)*
| Level of evidence (evidence [refs.] reviewed)† | |
|---|---|
| In adult patients with active PsA despite treatment with an OSM, | |
| 1. Switch to a TNFi biologic over a different OSM (PICO 23) | Moderate (62–66, 69–86) |
| Conditional recommendation based on moderate- quality evidence; may consider switching to a different OSM if the patient has contraindications to TNFi biologics, including congestive heart failure, previous serious infections, recurrent infections, or demyelinating disease, if the patient prefers an oral versus parenteral therapy, or in patients without evidence of severe PsA‡ or severe psoriasis.§ | |
| 2. Switch to a TNFi biologic over an IL-17i biologic (PICO 17) | Moderate (62–66, 72–78, 87–97) |
| Conditional recommendation based on moderate- quality evidence; may consider an IL- 17i if the patient has severe psoriasis and/or has contraindications to TNFi biologics, including congestive heart failure, previous serious infections, recurrent infections, or demyelinating disease, and/or a family history of demyelinating disease such as multiple sclerosis. | |
| 3. Switch to a TNFi biologic over an IL-12/23i biologic (PICO 16) | Moderate (62–66, 72–78, 97–102) |
| Conditional recommendation based on moderate- quality evidence; may consider an IL- 12/23i if the patient has severe psoriasis and/or contraindications to TNFi biologics, including congestive heart failure, previous serious infections, recurrent infections, or demyelinating disease, or prefers less frequent drug administration. | |
| 4. Switch to a TNFi biologic over abatacept (PICO 67) | Low (62–66, 72–78, 103, 104) |
| Conditional recommendation based on low- quality evidence; may consider abatacept if the patient has contraindications to TNFi biologics, including congestive heart failure, previous serious infections, recurrent infections, or demyelinating disease. | |
| 5. Switch to a TNFi biologic over tofacitinib (PICO 76) | Low (62–66, 72–78, 105) |
| Conditional recommendation based on low- quality evidence; may consider tofacitinib if the patient has contraindications to TNFi biologics, including congestive heart failure, previous serious infections, recurrent infections, or demyelinating disease, or prefers oral medication. | |
| 6. Switch to an IL-17i over a different OSM (PICO 25) | Low (79–87, 89–95) |
| Conditional recommendation based on low-quality evidence; may consider switch- ing to a different OSM if the patient prefers an oral versus parenteral therapy or in patients without evidence of severe PsA or severe psoriasis. | |
| 7. Switch to an IL-17i biologic over an IL-12/23i biologic (PICO 18) | Moderate (87, 89–95, 98–100, 106, 107) |
| Conditional recommendation based on moderate-quality evidence; may consider an IL-12 /23i biologic if the patient has concomitant IBD or prefers less frequent drug administration. | |
| 8. Switch to an IL-17i biologic over abatacept (PICO 69) | Low (89–95, 103, 104) |
| Conditional recommendation based on low-quality evidence; may consider abata- cept in patients with recurrent or serious infections. | |
| 9. Switch to an IL-17i biologic over tofacitinib (PICO 78) | Low (89–95, 105) |
| Conditional recommendation based on low- quality evidence; may consider tofacitinib if the patient prefers an oral therapy or has a history of recurrent Candida infections. | |
| 10. Switch to an IL-12/23i biologic over a different OSM (PICO 24) | Low (79–86, 98–100) |
| Conditional recommendation based on low-quality evidence; may consider switch- ing to a different OSM if the patient prefers an oral versus parenteral therapy or in patients without evidence of severe PsA or severe psoriasis. | |
| 11. Switch to an IL-12/23i biologic over abatacept (PICO 68) | Low (98–100, 103, 104) |
| Conditional recommendation based on low-quality evidence; may consider abata- cept in patients with recurrent or serious infections. | |
| 12. Switch to an IL-12/23i biologic over tofacitinib (PICO 77) | Low (98–100, 105) |
| Conditional recommendation based on low-quality evidence; may consider tofaci- tinib if the patient prefers an oral therapy. | |
| 13. Add apremilast to current OSM therapy over switching to apremilast (PICO 22b) | Low (83, 84, 108) |
| Conditional recommendation based on low- quality evidence; may consider switching to apremilast if the patient has intolerable side effects with the current OSM. | |
| 14. Switch to another OSM (except apremilast) over adding another OSM (except apremilast) to current treatment (PICO 22a) | Low (83, 84, 108) |
| Conditional recommendation based on low-quality evidence; may consider adding another OSM (except apremilast) to current treatment if the patient has demonstrated partial response to the current OSM. | |
| 15. Switch to a TNFi biologic monotherapy over MTX and a TNFi biologic combi nation therapy (PICO 19) | Low (109–111) |
| Conditional recommendation based on low- quality evidence; may consider MTX and TNFi biologic combination therapy if the patient has severe skin manifestations, has had a partial response to current MTX therapy, has concomitant uveitis (since uveitis may respond to MTX therapy), and if the current TNFi biologic is infliximab or adalimumab. | |
| 16. Switch to an IL-17i biologic monotherapy over MTX and an IL-17i biologic combination therapy (PICO 21) | Very low |
| Conditional recommendation based on very- low-quality evidence; may consider MTX and an IL-17 i biologic combination therapy if the patient has severe skin manifestations, has had a partial response to current MTX therapy, or has concomitant uveitis (since uveitis may respond to MTX therapy). | |
| 17. Switch to an IL-12/23i biologic monotherapy over MTX and an IL-12/23i bio logic combination therapy (PICO 20) | Very low |
| Conditional recommendation based on very- low- quality evidence; may consider MTX and an IL-12 /23i biologic combination therapy if the patient has severe skin manifestations, has had a partial response to current MTX therapy, or has concomitant uveitis (since uveitis may respond to MTX therapy). |
Active psoriatic arthritis (PsA) is defined as disease causing symptoms at an unacceptably bothersome level as reported by the patient, and judged by the examining clinician to be due to PsA based on ≥1 of the following: swollen joints, tender joints, dactylitis, enthesitis, axial disease, active skin and/or nail involvement, and extraarticular inflammatory manifestations such as uveitis or inflammatory bowel disease (IBD). Oral small molecules (OSMs) are defined as methotrexate (MTX), sulfasalazine, leflunomide, cyclosporine, or apremilast and do not include tofacitinib, which was handled separately since its efficacy/safety profile is much different from that of other OSMs listed above. TNFi = tumor necrosis factor inhibitor; IL-17i = interleukin-17 inhibitor.
When there were no published studies, we relied on the clinical experience of the panelists, which was designated very-low-quality evidence.
Because there are currently no widely agreed-upon definitions of disease severity, PsA severity should be established by the health care provider and patient on a case-by-case basis. For the purposes of these recommendations, severity is considered a broader concept than disease activity in that it encompasses the level of disease activity at a given time point, as well as the presence of poor prognostic factors and long-term damage. Examples of severe PsA disease include the presence of ≥1 of the following: a poor prognostic factor (erosive disease, elevated levels of inflammation markers such as C-reactive protein or erythrocyte sedimentation rate attributable to PsA), long-term damage that interferes with function (e.g., joint deformities, vision loss), highly active disease that causes major impairment in quality of life (i.e., active psoriatic inflammatory disease at many sites [including dactylitis, enthesitis] or function-limiting inflammatory disease at few sites), and rapidly progressive disease.
Because there are currently no widely agreed-upon definitions of disease severity, psoriasis severity should be established by the health care provider and patient on a case-by-case basis. In clinical trials, severe psoriasis has been defined as a Psoriasis Area and Severity Index (PASI) score (25) of ≥12 and a body surface area score of ≥10. In clinical practice, however, the PASI tool is not standardly utilized given its cumbersome nature. In 2007, the National Psoriasis Foundation published an expert consensus statement, which defined moderate-to-severe disease as a body surface area of ≥5% (68). In cases in which the involvement is in critical areas, such as the face, hands or feet, nails, intertriginous areas, scalp, or where the burden of the disease causes significant disability or impairment of physical or mental functioning, the disease can be severe despite the lower amount of surface area of skin involved. The need to factor in the unique circum stances of the individual patient is of critical importance, but this threshold provides some guidance in the care of patients.